Esperion’s Nexletol and Nexlizet Receive FDA Approval for Broader Indications

March 29, 2024—Esperion recently announced that the FDA has approved new broad label expansions for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) tablets that include indications for cardiovascular risk reduction and expanded low-density lipoprotein cholesterol (LDL-C) lowering in both primary and secondary prevention patients.

In addition, the enhanced labels support use of Nexletol and Nexlizet either alone or in combination with statins. They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C–lowering nonstatin drugs indicated for primary prevention patients.

Esperion further advised that pending label expansions in Europe remain on track, with a positive opinion received from the Committee for Medicinal Products for Human Use on March 21, 2024. The company anticipates a final determination by the European Medicines Agency in the second quarter of 2024.

The United States approvals of Nexlizet and Nexletol for cardiovascular risk reduction and LDL-C lowering were based on data generated from the CLEAR Outcomes trial assessing the effect of Nexletol on cardiovascular outcomes in approximately 14,000 patients with or at high risk of cardiovascular disease (CVD). Patients were followed for a median duration of 3.4 years, and bempedoic acid (contained in Nexletol and Nexlizet) was generally safe and well tolerated.

In March 2023, the American College of Cardiology (ACC) announced that findings from CLEAR Outcomes were presented at ACC.23/WCC, the ACC’s annual scientific session together with the World Congress of Cardiology, held in New Orleans, Louisiana. The study was simultaneously published online by Steven E. Nissen, MD, et al in The New England Journal of Medicine (2023;388:1353-1364).

In the study, LDL-C was reduced by 20%, high-sensitivity C-reactive protein (hsCRP) was reduced by 22%, and glucose was not elevated by bempedoic acid compared to placebo. The company advised that patients who received bempedoic acid in the trial experienced a relative risk reduction of 15% for major adverse cardiovascular events-3 (MACE-3, defined as death from a cardiovascular cause, nonfatal stroke, or nonfatal myocardial infarction), 27% for nonfatal myocardial infarction, 19% for coronary revascularization, and 39% for MACE-3 in primary prevention patients.

The bempedoic acid component of Nexlizet and Nexletol is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with established CVD or at high risk for a CVD event but without established CVD.

Esperion stated that as an adjunct to diet, Nexlizet alone or in combination with other LDL-C–lowering therapies is indicated to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). Also as an adjunct to diet, Nexletolin in combination with other LDL-C–lowering therapies or alone when concomitant LDL-C–lowering therapy is not possible is indicated to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.